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Retrospective, Observational, Multi-center Study Evaluating the Efficacy and Tolerance of Brigatinib in the Management of Rearranged CBNPC ROS1 (BRIGAROS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04718012
Recruitment Status : Completed
First Posted : January 22, 2021
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Study Description
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Brief Summary:
ROS1 translocated Non small cell lung cancer (NSCLC) is a rare type of lung cancer with few datas. We collected datas concerning patients with ROS1 translocated NSCLC who received Brigatinib in the Compassionate Access after two others Tyrosine kinase Inhibitors

Condition or disease
Lung Cancer ROS Translocated

Detailed Description:

Lung cancer is the most common cancer worldwide and the leading cause of cancer death in Western countries. Non-small cell lung cancer (NSCLC) is the most usual form (80-85%) of lung cancers. Unfortunately, at the time of diagnosis, most patients present with metastatic or advanced disease. Significant advances have been made in recent years on knowledge of oncogenesis of NSCLC in particularly the discovery of specific oncogenic drivers playing key role in oncogenic addiction responsible for the occurrence of NSCLC.

ROS1 translocation is found in1 to 2 % of non small cell lung cancer. Due to this rare subtype of cancer, we have few datas. ROS1 translocation is found in a rather younger population, with a predominance of woman and non smoker. ROS1 translocation can be detected by immunohistochemistry and confirmed by FISH or RNA fusion technics.

Crizotinib demonstrated his interest in the phase 1 trial PROFILE 1001 with an objective response rate of 72% tested on 52 patients, the median progression free survival was 19,3 months, overall survival of 51% at 48 months.

Similar datas were found in different cohortes. A chinese study of 23 patients receiving crizotinib, the objective response rate was 56,5%, a median progression free survival of 14,5 months. A european retrospective cohorte EUROS1 of 30 patients receiving crizotinib found a progression free survival of 9,1 months, an objective response rate of 80% . A prospective european study EUCROSS included 34 patients with an objective response rate of 70% and a progression free survival of 20 months. The Acsé crizotinib cohorte included 37 patients ROS1 translocated, the objective response rate was lower at 47,2% in this study with heavily pretreated population.

Ceritinib has been studied in a phase 2 study of 32 patients in whom 30 patients where treatment naifs of crizotinib, the objective response rate was 62%.

Lorlatinib was studied in a phase1-2 trial, including 69 ROS1 patients, 21 were TKI naifs, 40 pretreated with crizotinib and 8 treated with one or two others TKI, with objective response rate of 62% in the naive population, and 41% on the entire cohorte.

More recently, Entrectinib demonstrated his interest in a pooled study of 3 trial, 53 patients were ROS1 translocated and had an objective response rate of 77% with this new molecule.

Few datas are available about brigatinib in ROS1 translocated patients, only three patients ROS1 were included in the brigatinib phase 1 trial. The aim of this study is to obtain more datas of efficacy, safety, among patients receiving Brigatinib with the compationnate access in France

Study Design
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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective, Observational, Multi-center Study Evaluating the Efficacy and Tolerance of Brigatinib in the Management of Rearranged CBNPC ROS1
Actual Study Start Date : March 17, 2021
Actual Primary Completion Date : October 17, 2021
Actual Study Completion Date : October 17, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Brigatinib

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival on Brigatinib in patients with ROS1 translocated CBNPCtransloated CBNPC [ Time Frame: 27 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 27 months ]
  2. Number of side effects associated with brigatinib [ Time Frame: 27 months ]
  3. Types of side efects associated with brigatinib [ Time Frame: 27 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with CBNPC when they visit the respiratory ward
Criteria

Inclusion Criteria:

  • patient with CBNPC transloated ROS1
  • Treatment by Brigatinib as part of compassionate access in France
  • Patient > 18 years old

Exclusion Criteria:

  • Refusal of the patient to participate in this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04718012


Locations
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France
CHI Créteil
Créteil, France, 94000
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
More Information
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT04718012    
Other Study ID Numbers: BRIGAROS
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal Creteil:
Brigatinib, lung cancer, ROS1
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases